Inflammatory Bowel DiseaseEarly Phase 1NCT02460705
Fecal Microbiota Transplant for Inflammatory Bowel Disease
A Early Phase 1 study testing Biologically active human fecal material, OpenBiome in people with Inflammatory Bowel Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation. This is a prospective, open label pilot study in which patients with symptoms of Inflammatory bowel disease will receive FMT therapy delivered via… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Biologically active human fecal material, OpenBiome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 4 Nov 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of Ulcerative Colitis confirmed by endoscopy and pathology and with a Mayo clinic ulcerative colitits disease activity score of 6 or greater.
- Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.
Who cannot join
- Female patients who are pregnant.
- Patients with severe immunosuppression (absolute neutrophil count < 1000 or CD4 count <200).
- Patients with untreated enteric infection.
- Patients with colon cancer or dysplasia
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Division of Gastroenterology at Mount Zion
San Francisco, California, 94143
About this study
Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.
This is a prospective, open label pilot study in which patients with symptoms of Inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.
The investigators hypothesize that FMT is a safe and effective treatment for patients with inflammatory bowel disease. The aims are:
- To determine if symptoms of inflammatory bowel disease can be successfully treated by Fecal Microbial Transplantation.
- To determine if endoscopic appearance of colon or ileum improves following treatment by Fecal Microbial Transplantation.
Read the detailed description
Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.
This is a prospective, open label pilot study in which patients with symptoms of acute or chronic inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.
Number of Subjects:
This study will aim to enroll approximately 60 patients with inflammatory bowel disease.
All patients who have IBD will be evaluated at the UCSF Center for Inflammatory Bowel Disease. Patients who are eligible for the study will be identified during these regularly scheduled clinic visits. Patients who express interest will be set up for a meeting with a clinical research coordinator who will go over the study in detail and will obtain informed consent.
Prior to the FMT procedure stool samples will be checked for ova and parasites, C. difficile toxin and fecal calprotectin. Serum tests will include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Anti-nuclear antibodies (ANA), complete blood cell count, HIV, screening for Hepatitis A, B, C (hep A IgM, hep B surface antigen and antibody, Hep C antibody), and creatinine. 8 days before treatment, patients will take a 5 day course of rifaximin that is discontinued 3 days before FMT treatment.
Patients with IBD will undergo colonoscopy, which is considered part of standard of care for patients with ongoing inflammation and is not considered a study procedure. The colonoscopies will be done in the endoscopic units at Mt. Zion, Parnassus and/or Mission Bay. During this procedure the fecal transplant will take place. For FMT, 250 cc of FMT material (previously screened stool from OpenBiome) will be administered via the endoscope. The scope will then be withdrawn and the patient will recover in the endoscopy unit as per protocol.
Patients who have undergone FMT for IBD will be called the next day to ensure no adverse events have occurred. Patients will be scheduled for a second FMT treatment and a follow up clinic visit 4 weeks after the inital FMT procedure. Patients will be contacted by phone 24 hours, 1 week, 1 month and and then every 3 months for 3 years after FMT treatment. A 6 month colonoscopy will be done to check for mucosal healing.
During each FMT procedure and the 6 month colonoscopy up to a total of 6 ileum and rectosigmoid biopsies will be obtained. In addition the investigators will collect research blood samples before the initial procedure, 1 and 6 months after the initial FMT treatment.
One week after the second FMT treatment, patients will be given the option to enroll in a 6 week, once per week FMT capsule therapy to be administered at a 1 hour clinic visit. Patients who receive capsules will be called the following to to ensure no adverse events have occurred.
Study participants will be asked to submit a stool sample prior to treatment, one month after treatment and then after that every 3 months after treatment up to 1 year in duration for a total of 6 samples. Study participants will also be administered a patient survey to assess their clinical outcomes/symptoms prior to treatment and again 1 month after receiving treatment. In addition, all patients will receive a phone call 24 hours, 1 week, 1 month and and then every 3 months for 3 years after FMT treatment.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Biologically active human fecal material, OpenBiome
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologically active human fecal material, OpenBiomeDrug
Fecal microbiota transplant
| Study group | Role | What they receive |
|---|---|---|
| IBD patients receiving FMT | Experimental | IBD patients receiving biologically active human fecal material sourced from OpenBiome. The physician will administer 250 mL of the fecal suspension in aliquots of 50-60 mL, through the endoscope. The material will be delivered to the most proximal point of insertion. Receives: Drug: Biologically active human fecal material, OpenBiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of IBD
In order to assess clinical improvement of IBD, patients will be scheduled for a 4 week post-FMT treatment clinic visit to assess patient symptoms.
Measured: 4 weeks
Secondary outcomes (1)
Efficacy of FMT treatment
Patients will complete a survey both before and 4 weeks after treatment to evaluate the efficacy of FMT treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion20 Dec 2016
- Study completion4 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najwa Elnachef, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460705
- Sponsor's protocol ID
- 15-16617
- Status last verified
- Jun 2018
- First submitted
- 28 May 2015
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gutin L, Piceno Y, Fadrosh D, Lynch K, Zydek M, Kassam Z, LaMere B, Terdiman J, Ma A, Somsouk M, Lynch S, El-Nachef N. Fecal microbiota transplant for Crohn disease: A study evaluating safety, efficacy, and microbiome profile. United European Gastroenterol J. 2019 Jul;7(6):807-814. doi: 10.1177/2050640619845986. Epub 2019 Apr 20.
PubMed 31316785
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02460705
- Acronym / sponsor ID
- 15-16617
- Conditions
- Inflammatory Bowel Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 4 Nov 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.
This is a prospective, open label pilot study in which patients with symptoms of Inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.
The investigators hypothesize that FMT is a safe and effective treatment for patients with inflammatory bowel disease. The aims are:
- To determine if symptoms of inflammatory bowel disease can be successfully treated by Fecal Microbial Transplantation.
- To determine if endoscopic appearance of colon or ileum improves following treatment by Fecal Microbial Transplantation.
Detailed description
Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.
This is a prospective, open label pilot study in which patients with symptoms of acute or chronic inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.
Number of Subjects:
This study will aim to enroll approximately 60 patients with inflammatory bowel disease.
All patients who have IBD will be evaluated at the UCSF Center for Inflammatory Bowel Disease. Patients who are eligible for the study will be identified during these regularly scheduled clinic visits. Patients who express interest will be set up for a meeting with a clinical research coordinator who will go over the study in detail and will obtain informed consent.
Prior to the FMT procedure stool samples will be checked for ova and parasites, C. difficile toxin and fecal calprotectin. Serum tests will include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Anti-nuclear antibodies (ANA), complete blood cell count, HIV, screening for Hepatitis A, B, C (hep A IgM, hep B surface antigen and antibody, Hep C antibody), and creatinine. 8 days before treatment, patients will take a 5 day course of rifaximin that is discontinued 3 days before FMT treatment.
Patients with IBD will undergo colonoscopy, which is considered part of standard of care for patients with ongoing inflammation and is not considered a study procedure. The colonoscopies will be done in the endoscopic units at Mt. Zion, Parnassus and/or Mission Bay. During this procedure the fecal transplant will take place. For FMT, 250 cc of FMT material (previously screened stool from OpenBiome) will be administered via the endoscope. The scope will then be withdrawn and the patient will recover in the endoscopy unit as per protocol.
Patients who have undergone FMT for IBD will be called the next day to ensure no adverse events have occurred. Patients will be scheduled for a second FMT treatment and a follow up clinic visit 4 weeks after the inital FMT procedure. Patients will be contacted by phone 24 hours, 1 week, 1 month and and then every 3 months for 3 years after FMT treatment. A 6 month colonoscopy will be done to check for mucosal healing.
During each FMT procedure and the 6 month colonoscopy up to a total of 6 ileum and rectosigmoid biopsies will be obtained. In addition the investigators will collect research blood samples before the initial procedure, 1 and 6 months after the initial FMT treatment.
One week after the second FMT treatment, patients will be given the option to enroll in a 6 week, once per week FMT capsule therapy to be administered at a 1 hour clinic visit. Patients who receive capsules will be called the following to to ensure no adverse events have occurred.
Study participants will be asked to submit a stool sample prior to treatment, one month after treatment and then after that every 3 months after treatment up to 1 year in duration for a total of 6 samples. Study participants will also be administered a patient survey to assess their clinical outcomes/symptoms prior to treatment and again 1 month after receiving treatment. In addition, all patients will receive a phone call 24 hours, 1 week, 1 month and and then every 3 months for 3 years after FMT treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients receiving FMT | Experimental | Drug: Biologically active human fecal material, OpenBiomeIBD patients receiving biologically active human fecal material sourced from OpenBiome. The physician will administer 250 mL of the fecal suspension in aliquots of 50-60 mL, through the endoscope. The material will be delivered to the most proximal point of insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with history of Ulcerative Colitis confirmed by endoscopy and pathology and with a Mayo clinic ulcerative colitits disease activity score of 6 or greater.
- Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.
Key exclusion criteria (4 listed)
- Female patients who are pregnant.
- Patients with severe immunosuppression (absolute neutrophil count < 1000 or CD4 count <200).
- Patients with untreated enteric infection.
- Patients with colon cancer or dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologically active human fecal material, OpenBiomeFecal microbiota transplant | Drug | IBD patients receiving FMT |
Primary outcome
Clinical improvement of IBD
Time frame: 4 weeks
In order to assess clinical improvement of IBD, patients will be scheduled for a 4 week post-FMT treatment clinic visit to assess patient symptoms.
1 secondary outcome
Efficacy of FMT treatment
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Derived from this study: PubMed 31316785Gutin L, Piceno Y, Fadrosh D, Lynch K, Zydek M, Kassam Z, LaMere B, Terdiman J, Ma A, Somsouk M, Lynch S, El-Nachef N. Fecal microbiota transplant for Crohn disease: A study evaluating safety, efficacy, and microbiome profile. United European Gastroenterol J. 2019 Jul;7(6):807-814. doi: 10.1177/2050640619845986. Epub 2019 Apr 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biologically active human fecal material, OpenBiome in people with Inflammatory Bowel Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement of IBD (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.